Reduction of Adverse Events of Anticholinergic Drugs by Multidisciplinary Medical Reviews in Norwegian Nursing Homes (PRADA)

U

Ullevaal University Hospital

Status

Completed

Conditions

Anticholinergic Side Effects

Treatments

Other: Multidisciplinary drug reviews by pharmacist and physician

Study type

Interventional

Funder types

Other

Identifiers

NCT00854438
1110

Details and patient eligibility

About

Thesis: Is drug-induced anticholinergic activity additive resulting in a total anticholinergic load causing harmful side effects in old, fragile patients? Is it possible to reduce the anticholinergic load by multidisciplinary medical review including a pharmacist and a physician? The effects of the medical reviews are measured by cognitive tests (MMS and CERADS word lists), a measure of mouth dryness, serum levels of anticholinergic activity, activity of daily living and neuropsychiatric symptoms. Design: A randomized, controlled, single blinded interventional study in Norwegian nursing homes.

Full description

Several studies have claimed that drugs showing anticholinergic activity in vitro cause high levels of serum anticholinergic activity in vivo that might cause impaired cognitive and functional functions in elderly. Pathophysiological changes in Alzheimer's dementia makes these patients particularly vulnerable for anticholinergic cognitive impairments. The PRADA-study is the first interventional study evaluating the clinical effects of reducing drug-induced anticholinergic load in patients with dementia. This is also the first interventional study in the Nordic countries evaluating the clinical effects of clinical pharmacy.

Enrollment

87 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Long-term nursing home patients with none, mild or moderate dementia (evaluated by CDR9,using drugs with a total anticholinergic burden that might lead to adverse events.

Exclusion criteria

  • Not able to perform the testes because of physical or psychiatric illnesses.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

87 participants in 2 patient groups

Active treatment arm
Experimental group
Description:
Reduction of anticholinergic drug effects by pharmacist review
Treatment:
Other: Multidisciplinary drug reviews by pharmacist and physician
Control
No Intervention group
Description:
No intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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